Core Viewpoint - Neurovalens has received FDA De Novo approval for its non-invasive weight management product, Modius Lean, which utilizes neurostimulation technology to aid in weight loss and body composition management [4][6][7]. Product Development - Modius Lean is designed to send gentle electrical pulses to the brain 60 minutes before sleep, helping to reduce visceral fat while maintaining lean body mass [6]. - The product has shown a clinically significant improvement, with a 13% average reduction in visceral fat over six months in a study involving 241 overweight and obese adults [6]. Market Strategy - With the De Novo approval, Neurovalens can now sell Modius Lean directly in the U.S. market with a prescription, marking a significant step in the company's long-term growth strategy [6][7]. - The company plans to expand its clinical research to include additional indications, having already submitted an application for PTSD [6]. Financial Background - Neurovalens has raised approximately £20 million (around $27 million), including an $8.1 million funding round completed earlier this year [6]. Industry Context - The CEO of Neurovalens highlighted that about three-quarters of adults in the U.S. are considered overweight or obese, indicating a growing market for low-risk, non-invasive treatment options like Modius Lean [7].

北京和上海活动报名： 第三届全球手术机器人大会 2025医疗器械研发创新论坛 2025年8月，医疗科技公司 Neurovalens 宣布完成一笔 600万英镑的融资 （约合5800万人民币） ，由 北爱 尔兰投资基金（IFNI） 领投。该融资在无创神经调控赛道中引起了广泛关注。 这笔融资的结构颇具代表性： 算上本轮，Neurovalens至今累计融资规模约 2000万英镑 。资金将主要用于三个方向：一是扩张美国市场， 二是加快监管审批进程，三是加速现有产品（Modius系列）的商业化销售。 如果单看金额，这只是英国本土医疗创新的一笔中型融资，但放到Neurovalens的发展轨迹里，它是一个重要 信号：公司已不再依赖研发故事，而是进入到" 靠销量验证价值 "的阶段。 IFNI通过Clarendon Fund Managers出资150万英镑； WhiteRock的Growth Capital Fund追加78万英镑； 老股东IQ Capital、Angel Co-Fund、Innovation Ulster继续跟投； 另外还有来自IFNI债务基金的100万英镑贷款支持。 # 公司与赛道：无创神经调控的代表 N ...